Most protocols qualify for exempt certification or expedited review. Only protocols that do not meet the exemption or expedited categories or have been determined to be above minimum risk are reviewed by the IRB full board.
Yes, as new areas of research and new issues arise regulations change or are added accordingly.
Yes, you must provide this permission as part of the IRB submittal package.
The University of Idaho reviews protocols for UI faculty/staff/students only. If you are an outside investigator and your planned activities will engage UI in your research you will need to seek a UI collaborator to submit your protocol to the UI IRB for review and approval. For activities that do not engage the UI in your research, e.g. contacting individuals associated with UI to recruit for your Human Subjects Research project no UI IRB approval is required or provided.
Note: Please refer to the following guidance document as to whether your planned activities will engage UI in your research activities: http://www.hhs.gov/ohrp/policy/engage08.html
While there are many measures that can be taken to protect confidentiality, UI is a state institution and data collected by faculty, staff and students can be requested through both the State Public Records Act and the federal Freedom of Information Act (FOIA).
Yes, the regulations are the minimum required, but the IRB has the regulatory authority to add additional safeguards as the body deems appropriate for the institution.
Download and fill out the required materials, complete the NIH course, and email your materials to your faculty sponsor. If acceptable, the faculty sponsor will forward the materials to the IRB for review.
It is necessary, but not sufficient. Must also have assent of child participant (>3 yrs.), Verbal assent (3-7 yrs.), written assent (>7yrs.)
In some cases (phone survey, anonymous survey, illiterate populations), other forms of consent may be better.
All research activities with human participants pose some level of risk. In some instances the level of risk may be considered minimal but for all non-exempt research these risks need to be listed and tied to appropriate risk mitigation measures.
No, participants can withdraw at any time without penalty.
Individuals required to complete Human Participants (NIH) training:
- Anyone involved in the direct collection of data from human subjects (including interviewers, focus group facilitators, transcribers, etc. whether they are UI faculty, staff, or students).
- The PI or direct supervisor of individuals who are involved in data collection from human subjects (includes faculty sponsor or advisor, if individual is a student).
- The PI or lead investigator for the human subjects component of an interdisciplinary project.
- Anyone who analyzes or examines data which can be linked to individual study participants.
- The lead PI on interdisciplinary grants in which there is a human subjects component of a project, even if the lead PI is not the researcher overseeing the human subjects component of the research.
Individuals not required to complete Human Participants (NIH)training:
- Individuals who only analyze secondary data (such as published U.S. Census Bureau data or other agency data) that is publically available and where individuals cannot be identified.
- Co-PI’s (whether at UI or not), other than the grant’s lead PI, on interdisciplinary projects that may have a human subjects component where the human subjects component is being overseen and/or conducted by a PI who does have IRB training. [Example: on a project examining the agronomic, environmental, and sociological factors surrounding the use of conservation practices in agriculture, the sociologist and his/her team should have IRB training, the grant’s lead PI (whether the sociologist or not) should have IRB training, but the hydrologist analyzing water quality data is not required to complete the training.]
- The lead PI on a grant awarded to another University or agency where a) the lead PI is not a UI employee, and b) UI is the subcontractor and the UI PI does have IRB training.